BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN PEG CMNTLS FMRL MD

    MDR report key: 15741919 · Received November 7, 2022

    Report

    Report Number
    0009613350-2022-00571
    Event Type
    Injury
    Date Received
    November 7, 2022
    Date of Event
    February 8, 2021
    Report Date
    November 21, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279442270
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXF ANAT BRG LT MD SIZE 3, PMA, ITEM#159547, LOT#369770; OXFORD CEMENTLESS TIBIA D LM, ITEM#US166576, LOT#3050476. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2022-00454, 3002806535-2022-00455.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2, G3, G6, H2, H6, H10 NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. THE REPORTED PRODUCT WAS REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: NO OBVIOUS RADIOGRAPHIC ABNORMALITY DETECTED IN EITHER THE UNICOMPARTMENTAL KNEE ARTHROPLASTIES WHICH ARE PLACED ON THE MEDIAL COMPARTMENTS. THE HARDWARE APPEARS INTACT WITHOUT PERIPROSTHETIC LUCENCIES. BONES APPEAR INTACT WITHOUT RADIOGRAPHIC ABNORMALITY. NO JOINT EFFUSION OF THE LEFT KNEE. SOFT TISSUES APPEAR UNREMARKABLE. OVERALL FIT, ALIGNMENT, AND BONE QUALITY APPEAR NORMAL. NO SIGNS OF LOOSENING, WEAR, RADIOLUCENCY, OR OTHER CONTRIBUTING FACTORS CAN BE IDENTIFIED RADIOGRAPHICALLY. NO ANATOMICAL OR IMPLANT COMPLICATIONS DETECTED RADIOGRAPHICALLY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A CLINICAL STUDY THAT SEVEN YEARS AFTER INITIAL KNEE ARTHROPLASTY, A PATIENT EXPERIENCED SEVERE PAIN AND INCREASED SWELLING IN THE KNEE. AN ASPIRATION OF THE JOINT WAS PERFORMED (RESULTS NOT PROVIDED). CORTISONE INJECTIONS WERE GIVEN WHICH PROVIDED ABOUT 2-3 WEEKS OF PAIN RELIEF. ADDITIONALLY, AN INJECTION OF PLATELET RICH PLASMA WAS ALSO GIVEN. NO REVISION HAS BEEN NOTED TO DATE. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2834315 OXF TWIN PEG CMNTLS FMRL MD KNEE PROTHESIS NRA BIOMET UK LTD. N/A 2503468 05019279442270

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10 NARRATIVE